drugset / Trial / NCT03597529
CHOCOlate MeLatonin for AdolescenT MigrainE
RandomizedParallel-groupOpen-labelTreatment
Summary
Existing treatments for acute migraine are not effective for all children and adolescents, and can cause side effects. Investigator propose a dose-finding study of melatonin for acute migraine treatment in children and adolescents to determine the best dose to bring forward in a future fully-powered efficacy trial.
Timeline
- Start
- 2017-09-25
- Primary completion
- 2019-12-01
- Completion
- 2019-12-01
Publications
- Background Victor TW, Hu X, Campbell JC, Buse DC, Lipton RB. Migraine prevalence by age and sex in the United States: a life-span study. Cephalalgia. 2010 Sep;30(9):1065-72. doi: 10.1177/0333102409355601. Epub 2010 Mar 12.
- Background Ambriz-Tututi M, Rocha-Gonzalez HI, Cruz SL, Granados-Soto V. Melatonin: a hormone that modulates pain. Life Sci. 2009 Apr 10;84(15-16):489-98. doi: 10.1016/j.lfs.2009.01.024. Epub 2009 Feb 15.
- Background Gitto E, Aversa S, Salpietro CD, Barberi I, Arrigo T, Trimarchi G, Reiter RJ, Pellegrino S. Pain in neonatal intensive care: role of melatonin as an analgesic antioxidant. J Pineal Res. 2012 Apr;52(3):291-5. doi: 10.1111/j.1600-079X.2011.00941.x. Epub 2011 Dec 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Melatonin | Small molecule | 1 mg | — |
| Subject | Melatonin | Small molecule | 2 mg | — |
| Subject | Melatonin | Small molecule | 4 mg | — |
| Subject | Melatonin | Small molecule | 8 mg | — |